NCT01740154

Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer

Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine how sunitinib (sunitinib malate) causes fatigue. Patients will be asked to complete a brief questionnaire (survey) to rate their levels of fatigue every two weeks while they are participating in this research study. The questionnaire takes approximately 10-15 minutes to complete and is 9 questions. A series of physical measurements for fatigue will be performed before the first dose of sunitinib and again (4) weeks later to see if there are any changes in physical level of fatigues

Detailed description

PRIMARY OBJECTIVES: I. To determine the mechanisms associated with sunitinib related fatigue by recording EMG signals during a submaximal elbow contraction, twitch force and TMS prior to and at the end of 4 weeks of sunitinib in metastatic RCC patients. OUTLINE: Patients receive sunitinib malate orally (PO) daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28. .

Conditions

• Fatigue
• Recurrent Renal Cell Cancer
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
PROCEDURE	transcranial magnetic stimulation	Undergo TMS
PROCEDURE	electromyography	Undergo EMG
OTHER	survey administration	Ancillary studies
DRUG	sunitinib malate	Given PO

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-12-04
• Last updated: 2018-12-06
• Results posted: 2018-12-06

Locations

1 site across 1 country: United States